Abdominoplasty SurgeryNCT06486298
Comparison Between Vacuum Drain and Passive Drain In Abdominoplasty
A study testing Vacuum Drain and Passive Drain insertion at abdominoplasty surgery in people with Abdominoplasty Surgery, run by Sohag University at 1 site in Egypt.
Trial summary
The aim of the present study is to: Compare the subcutaneous collection with Vacuum Drain and Passive Drain insertion at abdominoplasty surgery Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Abdominoplasty Surgery
- What is being tested?
- Vacuum Drain and Passive Drain insertion at abdominoplasty surgery
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2023to 1 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Cooperative male and female patients aged between 20-60 years old.
- All patients in the study presented with varying degrees of excess abdominal skin and adipose tissue, along with a range of underlying abdominal muscle laxity, following volumetric changes of the abdominal cavity.
- These patients may undergo after bariatric surgery, dietry weight loss or after multiple pregnancies.
Who cannot join
- • Uncooperative patients unwilling to give consent.
- Those unsuitable for abdominoplasty surgery, BMI >30 and those on antiplatelet medication.
- Unfit for surgery and patients with allergies to any of the anesthesia components.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sohag Hospital University
Sohag
pola fayez fanos, 01228191595, polafayezplastic@gmail.com
01228191595, polafayezplastic@gmail.com
About this study
Official title: Comparison Between Vacuum Drain and Passive Drain In Abdominoplasty : Randomized Clinical Study
The aim of the present study is to:
Compare the subcutaneous collection with Vacuum Drain and Passive Drain insertion at abdominoplasty surgery
- Conditions
- Abdominoplasty Surgery
- Being tested
- Vacuum Drain and Passive Drain insertion at abdominoplasty surgery
- Keywords
- abdominoplasty surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vacuum Drain and Passive Drain insertion at abdominoplasty surgeryDevice
Compare the subcutaneous collection with Vacuum Drain and Passive Drain insertion at abdominoplasty surgery
| Study group | Role | What they receive |
|---|---|---|
| Vacuum Drain insertion at abdominoplasty surgery | Active comparator | insert the active drain after adominoplasty with radivac container Receives: Device: Vacuum Drain and Passive Drain insertion at abdominoplasty surgery |
| Passive Drain insertion at abdominoplasty surgery | Experimental | insert the passive drain after adominoplasty with collecting bag Receives: Device: Vacuum Drain and Passive Drain insertion at abdominoplasty surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
the subcutaneous collection with vaccum drain
the subcutaneous collection with Vacuum Drain at abdominoplasty surgery regarding : Incidence of postoperative complications
Measured: 10 days
the subcutaneous collection with passive drain
the subcutaneous collection with passive Drain at abdominoplasty surgery regarding : Incidence of postoperative complications
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Dec 2023
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominoplasty SurgeryStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pola Fayez Fanos, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06486298
- Sponsor's protocol ID
- Soh-Med-23-12-10MS
- Status last verified
- Jun 2024
- First submitted
- 19 Mar 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Vacuum Drain and Passive Drain In Abdominoplasty : Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT06486298
- Acronym / sponsor ID
- Soh-Med-23-12-10MS
- Conditions
- Abdominoplasty Surgery
- Keywords
- abdominoplasty surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the present study is to:
Compare the subcutaneous collection with Vacuum Drain and Passive Drain insertion at abdominoplasty surgery
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vacuum Drain insertion at abdominoplasty surgery | Active comparator | Device: Vacuum Drain and Passive Drain insertion at abdominoplasty surgeryinsert the active drain after adominoplasty with radivac container |
| Passive Drain insertion at abdominoplasty surgery | Experimental | Device: Vacuum Drain and Passive Drain insertion at abdominoplasty surgeryinsert the passive drain after adominoplasty with collecting bag |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- • Cooperative male and female patients aged between 20-60 years old.
Key exclusion criteria (3 listed)
- • Uncooperative patients unwilling to give consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vacuum Drain and Passive Drain insertion at abdominoplasty surgeryCompare the subcutaneous collection with Vacuum Drain and Passive Drain insertion at abdominoplasty surgery | Device | Passive Drain insertion at abdominoplasty surgery, Vacuum Drain insertion at abdominoplasty surgery |
Primary outcome
the subcutaneous collection with vaccum drain
Time frame: 10 days
the subcutaneous collection with Vacuum Drain at abdominoplasty surgery regarding : Incidence of postoperative complications
the subcutaneous collection with passive drain
Time frame: 10 days
the subcutaneous collection with passive Drain at abdominoplasty surgery regarding : Incidence of postoperative complications
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vacuum Drain and Passive Drain insertion at abdominoplasty surgery in people with Abdominoplasty Surgery, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the subcutaneous collection with vaccum drain (time frame: 10 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.